CMTBC Education Day April 13, 2014

Donelda Gowan-Moody, MT, MSc, PhD studentDepartment of Community Health & Epidemiology University of Saskatchewan

1) There are gaps in what we know about the ‘adverse’

2) Clarity and consensus is needed

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what we do know about adverse events (AEs) in MT

what relevant research others have done

what we need to do – explore views

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Patient safety is an important domain of population health and a Canadian national priority (Baker, 2004) - do no harm

Few data on professions that use manual therapies – physiotherapy, osteopathy, MT

Few data on manual therapies –massage, mobilization and manipulation, acupuncture

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WHO International Classification for Patient Safety – key concepts, conceptual framework, consensus

JCAHO Patient Safety Event Taxonomy – impact, type, domain, cause, prevention

Common Terminology Criteria for Adverse Events (v4.02) National Cancer Institute

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Adverse reaction: an unintended noxious response under normal dosage.

Adverse event/adverse experience: Any untoward medical occurrence ;does not necessarily have a causal relationship

Side effect: Any unintended effect related to the pharmacological properties of the drug.

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Adverse event: An event that results in unintended harm to the patient, and is related to the care and/or services provided to the patient rather than to the patient’s underlying medical condition (Canadian Patient Safety Institute)

Harm: An outcome that negatively affects the patient’s health and/or quality of life (CPSI)

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Posadzki P, Ernst E. The safety of massage therapy: an update of a systematic review. Focus on Alternative and Complementary Therapies. 2013;18(1):27-32

17 case reports and 1 case series

Updates Ernst (2003) - 16 case reports and 4 case series

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Chen et al. Small bowel intramural hematoma secondary to abdominal massage. Am J Emerg Med. 2013 Apr;31(4):758 e3-4. PubMed PMID: 23380131.

Jabr FI. Massive Pulmonary Emboli after Legs Massage. Am J Phys Med Rehabil. 2007; 86(8): 691.

Chakrapani et al. Bilateral Carotid and Bilateral Vertebral Artery Dissection Following Facial Massage. Angiology. 2009;59(6):761-4.

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Lee et al. Cervical cord injury after massage. Am J Phys Med Rehabil. 2011;90(10):856-9.

Guo et al. Isolated unilateral vertebral pedicle fracture caused by a back massage in an elderly patient: a case report and literature review Eur J Orthop Surg Traumatol [Internet]. 2012.

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Aksoy et al. Spinal accessory neuropathy associated with deep tissue massage: a case report. Archives of physical medicine and rehabilitation. 2009;90(11):1969-72.

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Grant KE. Massage safety: injuries reported in Medline relating to the practice of therapeutic massage-1965-2003. J Bodyw Mov Ther. 2003;7(4):207-12

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Average annual rate of claims per 1000 insured = 1.8 claims per 1000 massage therapists from 1993-1996

Studdert D, Eisenberg D, Miller F, Curto D, Kaptchuk T, Brennan T. Medical malpractice implications of alternative medicine/. The Journal of the American Medical Association. 1998;280:1610-5.

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Cambron JA, Dexheimer J, Coe P, Swenson R. Side-Effects of Massage Therapy: A Cross-Sectional Study of 100 Clients. J Altern Complement Med. 2007;13(8):793-96

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International Journal of Therapeutic Massage and Bodywork: Research, Education, and Practice http://www.ijtmb.org/index.php/ijtmb

Peer-reviewed, indexed in PubMed, Subscription-free open-access, Electronic

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Patient safety in community-based healthcare: Understanding adverse events in massage therapy

Purpose: to develop a clear definition of adverse events (AEs) in massage therapy to facilitate understanding of patient safety issues and aid recording and prevention of AEs in MT

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This project was approved on ethical grounds by the University of Saskatchewan Behavioural Research Ethics Board.

Your participation is voluntary and you can answer only those questions that you are comfortable with. You may withdraw from participation for any reason, at any time without explanation or penalty of any sort.

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What are the gaps?Does the evidence presented link in

any way to practice?What are the concepts for which we

should seek clarity? Other insights?

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How do patients receiving manual therapy through Ontario chiropractic, physiotherapy or osteopathic care define and interpret AEs associated with manual therapy techniques?

Manual tx = joint manipulation or mobilization NOT soft tissue

Carlesso et al, 201121

Functional impact

Changes in symptom location or quality

Neurologic-type symptoms

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Patients with LBP will identify adverse responses 51% more

Patients with an expectation of posttreatment soreness are 9% less likely to identify an adverse response

Being advised about potential; or getting better overall are important

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Carlesso LC, Gross AR, Santaguida PL, Burnie S, Voth S, Sadi J. Adverse events associated with the use of cervical manipulation and mobilization for the treatment of neck pain in adults: a systematic review. Manual Therapy. 2010 Oct;15(5):434-44

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Johnson et al (2012) demonstrated that "massage" as a physical therapy modality was in the top 5 treatments causing injury.

ExerciseSpinal manipulation or joint mobilizationTapingHeatMassage and acupuncture

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Carnes et al,2010 Adverse events and manual therapy: a systematic review.

Manual therapy: any techniques administered manually, using touch, by a trained practitioner for therapeutic purposes

Advice, through soft tissue massage and passive or active mobilisation, to manipulation

Statutory registered/ regulated professional

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Meta-analysis of RCTs - major AE: 0.13% (0/2301 txs)Minor or moderate: 22% (11.1-36.2)

From the cohort studies – Major AE: 0.007% (0/42 451)Minor or moderate: 41% 95% CI (17-

68%)

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Constructs measured on a 6 point rating scale:

For example:Level of distressTreatment alterations required or noExpected or UnexpectedAcceptable or Unacceptable

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Study aim: to investigate how osteopathic patients view post-treatment experiences and what meaning they ascribe to them

Conducted focus groups with patients from a teaching clinic

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Perceptions evolve; clinical change is evaluated within the context of their ‘global osteopathic experience’

Non-clinical factors, such as feeling respected, understanding through education and service efficiency

Clinical factors – function and quality of life

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Masunaga Shiatsu: a Japanese body-based life-energy therapy.

Zen or Masunaga: a theoretical framework

Holistic, mind-body approach

Transition effects: healing crisis

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Type 1 – unrelatedType 2 – Transitional – client describes

experience as initially (-) then (+)Type 3 – Transitional- consistent with

modality theory (example feeling exhausted)

Type 4 – Undesired event or effect but no risk to safety; distressing and interferes

Type 5 - Potentially adverse events or effects – may represent a risk to client safety

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Is there anything useful here from what others have done?

Is MT in any way unique?

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What puts the adverse in 'adverse events'?

What are the potential negative consequences of massage therapy treatment?

What is the common terminology used in describing negative experiences in massage therapy?

What elements would be necessary in a classification system for adverse events?

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What are the important constructs for providing meaning for adverse events?

What are the important descriptors for categories of adverse events?

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• scarce data, inconsistent aims, and disparate conceptualizations of adverse events

• there are disparate conceptualizations of manual therapy and massage therapy.

• There remains a gap in the understanding of patient safety in massage therapy.

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1) To describe and define the attributes of the concept of AEs in MT as compared to other manual therapies and medicine

2) To develop a conceptual taxonomic framework

3) To develop and pilot a data collection tool to be used in gathering, evaluating and reporting AEs in MT. 37

I gratefully acknowledge the Department of Community Health & Epidemiology for scholarship support.

The CMTBC and MTABC for their ongoing support of this work.

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Baker G. R., Norton P. G., Flintoft V., Blais, R., Brown, A., Cox, J., Etchells, E., Ghali, W. A., Hébert, P., Majumdar, S. R., O’Beirne, M., Palacios-Derflingher, L., Reid, R. J., Sheps, S. & Tamblyn, R. (2004). The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. Canadian Medical Association Journal, 170, 1678-1686

World Health Organization (2009). Final Technical Report for the Conceptual Framework for the International Classification for Patient Safety v.11. Geneva, Switzerland: Author. Retrieved from http://www.who.int/patientsafety/taxonomy/icps_full_report.pdf

Andrew Chang et al. “The JCAHO patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events.” International Journal for Quality in Health Care17, no. 2 (2005): 95-105

Ernst E. The safety of massage therapy. Rheumatology. 2003;42:1101-6Posadzki P, Ernst E. The safety of massage therapy: an update of a

systematic review. Focus on Alternative and Complementary Therapies. 2013;18(1):27-32

Grant KE. Massage safety: injuries reported in Medline relating to the practice of therapeutic massage-1965-2003. J Bodyw Mov Ther. 2003;7(4):207-12

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Runciman W, Hibbert P, Thomson R, Van Der Schaaf T, Sherman H, Lewalle P. Towards an International Classification for Patient Safety: key concepts and terms. International Journal for Quality in Health Care. 2009 February 1, 2009;21(1):18-26.

Carlesso LC, Cairney J, Dolovich L, Hoogenes J. Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Man Ther. 2011 Oct;16(5):440-6.

Johnson GM, Skinner MA, Stephen RE. Lessons to be learned: a retrospective analysis of physiotherapy injury claims. Journal of Orthopaedic & Sports Physical Therapy. 2012;42(8):698-704. PubMed PMID: 22711215.

Carlesso LC, MacDermid JC, Santaguida PL, Thabane L. A survey of patient's perceptions of what is "adverse" in manual physiotherapy and predicting who is likely to say so. J Clin Epidemiol. 2013 Oct;66(10):1184-91

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Carnes D, Mars TS, Mullinger B, Froud R, Underwood M. Adverse events and manual therapy: a systematic review. Man Ther. 2010 Aug;15(4):355-63

Carnes D, Mullinger B, Underwood M. Defining adverse events in manual therapies: a modified Delphi consensus study. Man Ther. 2010 Feb;15(1):2-6

Rajendran D, Bright P, Bettles S, Carnes D, Mullinger B. What puts the adverse in 'adverse events'? Patients' perceptions of post-treatment experiences in osteopathy--a qualitative study using focus groups. Man Ther. 2012 Aug;17(4):305-11

Long AF, Esmonde L, Connolly S. A typology of negative responses: A case study of shiatsu. Complementary therapies in medicine. 2009 6//;17(3):168-75.

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1) There are gaps in what we know

2) Clarity and consensus is needed

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